Diphenhydramine HCL

Product NDC
66424-021
11-digit product format
664240021
Labeler code
66424
Product ID
66424-021_2ba30474-41ba-6c1a-e063-6394a90a9631
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
SDA Laboratories, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-27
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66424-021-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66424-021-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66424-021-10IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66424-021-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66424-021-10IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66424-021-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66424-021-10IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66424-021-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66424-021-10IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66424-021-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66424-021-10IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66424-021-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66424-021-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66424-021-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66424-021-10EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66424-021-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020477Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
437e6a13-a4ff-4f98-8973-042f224ee85eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
66424-021-012023-06-13Drug Facts
66424-021-102023-06-13Drug Facts
66424-021-012020-01-31Drug Facts
66424-021-102020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66424-021-01Diphenhydramine HCL100 in 1 BOTTLE, PLASTICCAPSULE1003
66424-021-10Diphenhydramine HCL1000 in 1 BOTTLE, PLASTICCAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66424-021-01EA - Each66424-0219776653f-7c63-4b8b-a643-b1ff6450406412012-07-24
66424-021-10EA - Each66424-021fa4dd348-3929-4217-a7fb-c7f312f780c812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66424-021DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]3Current NDC, Legacy NDC, 2 package rows20250115_437e6a13-a4ff-4f98-8973-042f224ee85e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 26 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWALMART INC.321430a5-11c9-4d33-8638-5149f601f1bb2026-05-22WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLDolgencorp Incddcc1e78-4ea8-4489-88e7-86ff460164642026-05-21WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTHACETAMINOPHEN, DEXTROMETHORPHAN HBRAMERISOURCE BERGEN45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e2026-05-21WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC525467fb-510d-0b4b-e063-6294a90acd362026-05-21WarningsExact identifier
application number: M012
Mucinex ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4cee80e5-e412-e832-e063-6394a90aeb902026-05-21WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRReckitt Benckiser LLC4a9464cf-0c77-23d0-e063-6394a90a62f12026-05-21WarningsExact identifier
application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4ceda68e-c7ce-eb87-e063-6394a90a8ded2026-05-21WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.5258ea3f-87f1-7f86-e063-6394a90ab82f2026-05-21WarningsExact identifier
application number: M012
RELIABLE-1 ANTI DRIP PUMP MISTOXYMETAZOLINE HYDROCHLORIDEReliable 1 Laboratories LLC7df9905d-09aa-4c84-8b6f-6e5ed90df0da2026-05-21WarningsExact identifier
application number: M012
daytime nitetimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Inc80abb6b8-b0d5-4f19-8588-50b8717510bb2026-05-21WarningsExact identifier
application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEFOXYMETAZOLINE HYDROCHLORIDEFAMILY DOLLAR SERVICES INC27163169-54d0-4b6e-94cd-721b29b182492026-05-20WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Cough FastACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5241b11a-72c8-5e67-e063-6394a90a43532026-05-20WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC50b140ad-aba2-ce6b-e063-6294a90ae2f82026-05-20WarningsExact identifier
application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC4bae240c-70ce-e9c2-e063-6394a90a5f3d2026-05-20WarningsExact identifier
application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC85f7d60b-32ec-4ec2-86ec-f677093bce1d2026-05-20WarningsExact identifier
application number: M012
Chloraseptic Nighttime Sore Throat Hot ReliefACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEPrestige Brands Holdings, Inc.9c13c052-a5d1-43d2-8d29-4ea011a971ac2026-05-20WarningsExact identifier
application number: M012
Cold and Flu Severe, Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporationa0bff310-2d35-4a18-815b-8386e44730a22026-05-19WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.61a1beb3-decf-4c8d-a402-93a02ec40a432026-05-19WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC52291746-2bbf-8f3f-e063-6294a90adcfc2026-05-19WarningsExact identifier
application number: M012
MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift KickstartACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCIReckitt Benckiser LLCfdb70793-5dd1-0455-e053-6394a90ac6212026-05-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3ac0beba-303d-404e-bfec-0cf8c0e8624d12
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3ac0beba-303d-404e-bfec-0cf8c0e8624d12
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3ac0beba-303d-404e-bfec-0cf8c0e8624d12
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3ac0beba-303d-404e-bfec-0cf8c0e8624d12
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3ac0beba-303d-404e-bfec-0cf8c0e8624d12
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNc1873a4c-661f-4896-bcc0-f6d3a655de945
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN6e91b9c3-57e8-488b-ac70-d863cdf9d6e85
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDc1873a4c-661f-4896-bcc0-f6d3a655de945
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD6e91b9c3-57e8-488b-ac70-d863cdf9d6e85
1020477diphenhydramine HCl 50 MG Oral CapsuleSYc1873a4c-661f-4896-bcc0-f6d3a655de945
1020477diphenhydramine HCl 50 MG Oral CapsuleSY6e91b9c3-57e8-488b-ac70-d863cdf9d6e85
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3dbdf020-ca17-1197-e054-00144ff8d46c4
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN489645ad-d7da-5f52-e054-00144ff8d46c4
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD489645ad-d7da-5f52-e054-00144ff8d46c4
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3dbdf020-ca17-1197-e054-00144ff8d46c4
1020477diphenhydramine HCl 50 MG Oral CapsuleSY489645ad-d7da-5f52-e054-00144ff8d46c4
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3dbdf020-ca17-1197-e054-00144ff8d46c4
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN437e6a13-a4ff-4f98-8973-042f224ee85e3
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD437e6a13-a4ff-4f98-8973-042f224ee85e3
1020477diphenhydramine HCl 50 MG Oral CapsuleSY437e6a13-a4ff-4f98-8973-042f224ee85e3
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNc46e1443-dffe-47a9-bc9a-acbe3a8b0b411
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDc46e1443-dffe-47a9-bc9a-acbe3a8b0b411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66424-021-0166424002101100 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-01) 100 capsule2010-01-27NoNoCurrent
66424-021-10664240021101000 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-10) 1000 capsule2010-01-27NoNoCurrent